Omalizumab

Generic name
Omalizumab
Brand name
ATC Code
R03DX05
Compare …

Omalizumab

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Improving asthma control in severe persistent asthma
  • Subcutaneous
    • 6 years up to 18 years
        • The dose and dosing frequency are determined by the total IgE serum concentration measured before the start of the treatment, and by the bodyweight – see table below.
        • Treatment by a paediatric specialist (pulmonologist) who has experience with the use of omalizumab for this indication.

        DOSAGE REGIMEN (dosage in mg/dose)
        Pay attention to the difference in dosing frequency(every 4 weeks versus every 2 weeks)
        X = no data available for dosage recommendation

        initial
        value
        of IgE        		≥20-
        25 kg        		>25-
        30kg        		>30-
        40kg        		>40-
        50kg        		>50-
        60kg        		>60-
        70kg        		>70-
        80kg        		>80-
        90kg        		>90-
        125kg        		>125-
        150 kg
        ≥30-100 75
        mg/
        4 weeks        		 75
        mg/
        4 weeks        		 75
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks
        >100-200 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks
        >200-300 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks
        >300-400 225
        mg/
        4 weeks        		 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks
        >400-500 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks
        >500-600 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X
        >600-700 300
        mg/
        4 weeks        		 225
        mg/
        2 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 X X
        >700-800 225
        mg/
        2 weeks        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X
        >800-900 225
        mg/
        2 weeks        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X
        >900-1000 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X
        >1000
        -1100        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X
        >1100
        -1200        		 300
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X
        >1200
        -1300        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 X X X X X X
        >1300
        -1500        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X X
Chronic urticaria
  • Subcutaneous
    • 6 years up to 12 years

      • There are only a few case descriptions available about the use of omalizumab in chronic urticaria in children. Properly substantiated dose recommendations can therefore not be given. A description of the cases therefore follows:

        • 300 mg every 2 weeks: 10-year-old girl [Netchiporouk 2015]
        • 300 mg every 4 weeks: 8-year-old boy [Viswanathan 2013]
        • 150 mg every 2 weeks: 10-year-old boy [Uysal 2014]
        • 150 mg every 4 weeks: 7 and 10-year-old [Sussman 2014], 4 and 5-year-old girls [Netchiporouk 2015]

        When the urticaria goes into remission, the dose is reduced.
        Treatment by a paediatric allergologist or pediatric dermatologist who has experience with using omalizumab for this indication.

    • 12 years up to 18 years
      • 300 mg/dose every 4 weeks.

      • Treatment by a paediatric allergologist or pediatric dermatologist who has experience with the use of omalizumab for this indication.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

< 12 years:
Very common (> 10%): , fever.

Common (1-10%): headaches; epigastric distress.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Xanthines
R03DA04
Leukotriene receptor antagonists
R03DC03
Other systemic drugs for obstructive airway diseases
R03DX09
R03DX11

References

  1. Novartis Europharm Limited., SPC Xolair( EU/1/05/319/002-4) 14-4-2015, www.geneesmiddeleninformatiebank.nl
  2. Sussman G et al. , Real-life experiences with omalizumab for the treatment of chronic urticarial. , Ann Allergy Asthma Immunol., 2014, Feb;112(2):, 170-4
  3. Uysal P et al. J , An algorithm for treating chronic urticaria with omalizumab: dose interval should be individualized. , Allergy Clin Immunol., 2014, Mar;133(3):, 914-5.e2
  4. Viswanathan RK et al. 2013, Retrospective analysis of the efficacy of omalizumab in chronic refractory urticarial., Allergy Asthma Proc., 2013, Sep-Oct;34(5):, 446-52
  5. Netchiporouk E et al., Management of pediatric chronic spontaneous and physical urticaria patients with omalizumab: case series., Pediatr Allergy Immunol., 2015, Sep;26(6), 585-8
  6. Sussman G et al., Real-life experiences with omalizumab for the treatment of chronic urticarial., Ann Allergy Asthma Immunol., 2014, Feb;112(2):, 170-4
  7. Uysal P et al. J, An algorithm for treating chronic urticaria with omalizumab: dose interval should be individualized., Allergy Clin Immunol., 2014, Mar;133(3):, 914-5.e2

Changes

Therapeutic Drug Monitoring


Overdose